CARE Program, Department of Pediatrics, Faculty of Medicine and Dentistry, and Integrative Health Institute, University of Alberta, Suite #1702, College Plaza 8215 112 St. NW, Edmonton, AB, T6G 2C8, Canada.
Women's College Research Institute, Women's College Hospital, Department of Medicine, University of Toronto, 76 Grenville St, Toronto, ON, M5S 1B1, Canada.
Syst Rev. 2017 Jul 6;6(1):132. doi: 10.1186/s13643-017-0525-4.
N-of-1 trials are multiple cross-over trials done in individual participants, generating individual treatment effect information. While reporting guidelines for the CONSORT Extension for N-of-1 trials (CENT) and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) already exist, there is no standardized recommendation for the reporting of N-of-1 trial protocols.
The objective of this study is to evaluate current literature on N-of-1 design and reporting to identify key elements of rigorous N-of-1 protocol design.
We will conduct a systematic search for all N-of-1 trial guidelines and protocol-reporting guidelines published in peer-reviewed literature. We will search Medline, Embase, PsycINFO, CINAHL, the Cochrane Methodology Register, CENTRAL, and the NHS Economic Evaluation Database. Eligible articles will contain explicit guidance on N-of-1 protocol construction or reporting. Two reviewers will independently screen all titles and abstracts and then undertake full-text reviews of potential articles to determine eligibility. One reviewer will perform data extraction of selected articles, checked by the second reviewer. Data analysis will ascertain common features of N-of-1 trial protocols and compare them to the SPIRIT and CENT items.
This systematic review assesses recommendations on the design and reporting of N-of-1 trial protocols. These findings will inform an international Delphi development process for an N-of-1 trial protocol reporting guideline. The development of this guideline is critical for improving the quality of N-of-1 protocols, leading to improvements in the quality of published N-of-1 trial research.
N-of-1 试验是在个体参与者中进行的多次交叉试验，可产生个体治疗效果信息。虽然已经有针对 N-of-1 试验的 CONSORT 扩展（CENT）和标准方案条目：干预试验建议（SPIRIT）的报告指南，但对于 N-of-1 试验方案的报告尚无标准化建议。
本研究旨在评估当前关于 N-of-1 设计和报告的文献，以确定严格的 N-of-1 方案设计的关键要素。
我们将对发表在同行评审文献中的所有 N-of-1 试验指南和方案报告指南进行系统搜索。我们将检索 Medline、Embase、PsycINFO、CINAHL、Cochrane 方法学登记处、CENTRAL 和 NHS 经济评价数据库。合格的文章将包含关于 N-of-1 方案构建或报告的明确指导。两名评审员将独立筛选所有标题和摘要，然后对潜在文章进行全文审查以确定合格性。一名评审员将对选定文章进行数据提取，由第二名评审员进行检查。数据分析将确定 N-of-1 试验方案的共同特征，并将其与 SPIRIT 和 CENT 项目进行比较。
本系统评价评估了 N-of-1 试验方案的设计和报告建议。这些发现将为 N-of-1 试验方案报告指南的国际 Delphi 开发过程提供信息。该指南的制定对于提高 N-of-1 方案的质量至关重要，从而提高已发表的 N-of-1 试验研究的质量。
